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Nutraceuticals, F&B, Quality
QSM, Quality System, ISO
About Our Client
My client is a leader in the Nutraceutical industry that is expanding their business in the NA region.
- Manage all aspects of Quality and Compliance for the Swisse & Healthy Times business in USA, in order to deliver a high and consistent standard of products that meet regulatory and customer requirements.
- Management of quality aspects of Third Party Manufacturers of Swisse & Healthy Times products for USA.
- Demonstrate strong technical knowledge and understanding of each product.
- Notify senior management of significant quality challenges that may impact product quality, regulatory compliance (e.g. OOS, OOT) or supply, as well as key Quality & Compliance metrics.
- Utilise and communicate appropriate risk management during product disposition decisions.
- Production specification generation and reviews, with high attention to detail and complete accuracy
- Management and implementation of the Quality Agreements and relevant aspects of licensing/sourcing agreements as required
- Review and investigation of customer complaints
- Development, review and approval of company SOP's and other controlled procedures, as required
- Review and approve PQRs, as necessary
- Review and management of stability programs and other data supporting products, as necessary
- Execution of Change Controls and management of Deviations (internal and external)
- Participate in cross-team activities and global projects
- Ongoing review of processes and the potential for improvement
- Implement and promote the Swisse pledge for benchmark standards
- Implement OH&S standards and showing initiative in maintaining a happy, positive work environment and a clean and organised office
- Continually analyse and assess personal performance and discuss via key accountabilities with staff and manager at regular performance appraisal meetings
The Successful Applicant
- Minimum 5 years' experience in Pharmaceutical, Dietary Supplements, or Food industries, mainly in the areas of Manufacturing, QA/QC and Regulatory Affairs
- Solid understanding of regulatory requirements for dietary supplements / food products, including a strong working knowledge of Quality Risk Management and Compliance.
- Good understanding of the General Principles and Requirements of Food Law and USA FDA CFR related to this, and any other additional legal requirements for the products in USA as agreed.
- Good background in cross-cultural communications and management.
- Technical degree is required
What's on Offer
Good Salary compensation and excellent career track